780657
BioMed Laboratories, LLC. — FEI 3006784948
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 20, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |